As the population in the United States continues to increase, especially among the aging, the ability for traditional healthcare providers, such as hospitals and doctors' offices, to effectively provide treatment becomes increasingly challenging. In addition, as the average age of the population continues to increase, the number of people requiring care for long-term illnesses, such heart disease, diabetes and the like also increases.
Accordingly, alternatives to traditional health providers are being developed to accommodate these greater healthcare needs. Also, more effective and efficient systems are being developed to attempt to reduce the number of medical personnel necessary to treat or monitor patients. Specifically, systems are being developed that enable patients to have their conditions monitored at home, such as by themselves or a visiting nurse, and to provide data related to various tests, such as blood pressure measurement, temperature, weight, blood glucose level, and the like, to a centralized database. These systems are then capable of organizing the data in an appropriate manner, and providing the data in an appropriate format to a healthcare provider, such a physician, who can review the data and determine whether the plan of care for the patient is sufficient or should be modified.
An example of a healthcare data manipulation and analysis system is described in U.S. Pat. No. 6,230,142 to Benigno, the entire content of which is incorporated herein by reference. According to the disclosure of the Benigno patent, a healthcare provider, such as a nurse, can obtain patient data during a visit with the patient at, for example, the patient's home. This patient data is entered into a database that compares the data to treatment guidelines for the particular patient's disease, and provides a recommended course of treatment for the patient. Other examples of this type of system are described in U.S. Pat. Nos. 5,953,704 and 5,583,758, both to McGilroy, the entire content of both of these patents being incorporated herein by reference.
Although the patents cited above describe systems which attempt to gather and analyze patient data and provide some recommended plan of treatment, these systems are not configured to outline different options of patient care. These systems also are not effective in illustrating to the care provider a comparison between other variations of care plans that could be followed based on variations in the patient data. Therefore, healthcare providers may find these types of systems insufficient because they provide only a specific result for the patient based on the specific patient test data, and not different options that could be provided to the patient were the test data to be different.
A system known as Staged Diabetes Management (SDM) has been developed to assist medical practitioners in managing a patient's disease by comparing patient data with a set of guidelines for treatment options. SDM is described in further detail in Mazze et al., Staged Diabetes Management, A systematic Approach; International Diabetes Center; Minneapolis, Minn., 2000, which is incorporated herein in its entirety.
Although the SDM technique has been very successful, it is somewhat difficult to implement in a practical sense because of the need to manually integrate patient data with the SDM guidelines. That is, when a healthcare provider uses the known SDM technique, the healthcare provider must manually compare the patient data, such as test measurements and the like, with the questions and criteria set forth in the decision paths. Based on this comparison, the healthcare provider manually determines the course of treatment to provide to the patient in view of the guidelines outlined in the decision path. Again, although this technique is successful in achieving the desired results, it may be somewhat difficult for a healthcare provider to use in a practical sense.
An improvement of the SDM concept is described in copending U.S. Patent Application of Tim H. Gordon et al., filed Nov. 1, 2001, entitled “System and Method for Integrating Data with Guidelines to Generate Displays Containing the Guidelines and Data,” the contents of which are expressly incorporated herein in their entirety. However, this improved system and method are still primarily intended for use by a health care professional, rather than a patient.
Home diabetes therapy requires the patient to carry out a prescribed regimen that involves self-testing blood glucose levels and administering an appropriate dose of insulin. Insulin has traditionally been injected by a hypodermic syringe, which suffers from numerous drawbacks. For example, syringes are not preloaded with medication, requiring the user to carry a separate medical vial. Syringes also require a degree of dexterity and sufficient visual acuity on the part of the patient to line up the needle of the syringe with the rubber septum on the medical vial and to ensure that the syringe is loaded with the proper dosage. As a result, unintentional needle pricks can occur.
To overcome the drawbacks of syringes, medication delivery pens have been developed, which facilitate the self-administration of medication such as insulin. Such delivery pens use prepackaged insulin and may be used repeatedly until the medication is exhausted. Mechanical and electronic pens are available to the patient. Electronic pens incorporate electronic circuitry that sets and/or indicates the appropriate dosage of insulin and stores data for subsequent downloading such as the time, date, amount of medication injected, and so on.
Glucose levels are monitored at periodic intervals to determine when another insulin injection should be taken or to determine how the user is responding to prior injections. The patient monitors blood levels by lancing a portion of the body with a lancet to take a blood sample. The blood sample is placed on a test strip that contains appropriate reagents for creating the chemical reactions necessary to measure glucose levels, which is subsequently analyzed by the blood glucose monitor. Typically, the patient then manually records the results, the time and date in a log book. To monitor glucose levels the patient is required to have available a lancet, test strips and a blood glucose monitor.
The self-treatment of diabetes therefore requires the patient to carry at least three devices: a medication delivery pen, a blood glucose monitor, and a lancet, as well as ancillary items such as test strips, lancets and needles. This can be inconvenient, and cumbersome to use.
A number of patents disclose systems that attempt to allow a patient to more conveniently perform the requisite procedures for treating diabetes. More particularly, U.S. Pat. No. 5,279,294, to Anderson et al., discloses a portable unit that includes a glucose monitor and a lancet. The monitor and lancet are integrated in the housing. The lancet is not an independent component operably distinct from the housing. Rather, the housing includes a spring-actuated hammer for driving a disposable lancet. Since the lancet is integrated with the housing, it cannot be removed and used separately from the housing. U.S. Pat. No. 5,536,249, to Castellano et al., discloses a medication delivery pen that is integrated with a blood glucose monitor. The pen and monitor are not independent units and thus cannot be used separately from one another.
U.S. Pat. No.6,192,891, to Gravel et al., which is expressly incorporated herein by reference in its entirety, discloses an integrated portable diagnostic and medication delivery system. The system includes a housing and a monitor disposed in the housing for monitoring a characteristic of a bodily fluid sample obtained from an individual. A medication delivery pen and a lancet are each removably mounted to the housing. The monitor, which may be integrated into the housing, may monitor blood glucose levels, for example, and the pen may be employed for the delivery of insulin.
While the above described systems facilitate the self-administration and monitoring of medication, there is a need for additional features and improvements for such systems. None of the known systems provide feedback to the patient in order to assist the patient in maintaining preset clinical values. While the Gravel device is capable of monitoring and recording dose and monitored substance levels in an electronic logbook, the device is a “measure only” device, and does not provide feedback to the patient other than displaying measured substance or dosage levels. Thus, where a patient is deviating from clinical targets, intervention is not possible until the various measurements recorded by the patient (and/or the device) are reviewed by a health care professional (HCP). Furthermore, because the device does not provide immediate feedback, the patient is unaware and therefore unable to take corrective action immediately.
Therefore there is a need for an improved medical therapy guidance system. Such a system would monitor a patient's progress based on recorded medication dose and property level measurements, and provide immediate feedback to inform the patient if they are on target, or if they are danger of deviating from their therapy target. Furthermore, it would be advantageous for a therapy guidance device to guide patients to perform self-assessments, and to inform patients of ways to take corrective actions in order to return to therapy targets. Finally, such a device would empower the patient to become a partner with their HCP in reaching a therapy goal.